Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens
Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens. Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicent...
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| Veröffentlicht in: | Kidney international 2004-09, Vol.66 (3), p.1193-1198 |
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| creator | Aronoff, George R. Bennett, William M. Blumenthal, Samuel Charytan, Chaim Pennell, J.Phillip Reed, John Rothstein, Marcos Strom, James Wolfe, Anthony Van Wyck, David Yee, Jerry |
| description | Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens.
Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores. |
| doi_str_mv | 10.1111/j.1523-1755.2004.00872.x |
| format | Article |
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Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.</description><identifier>ISSN: 0085-2538</identifier><identifier>EISSN: 1523-1755</identifier><identifier>DOI: 10.1111/j.1523-1755.2004.00872.x</identifier><identifier>PMID: 15327417</identifier><identifier>CODEN: KDYIA5</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; anemia ; Anemia - drug therapy ; Anemia - etiology ; Anemia - mortality ; Anemias. Hemoglobinopathies ; Biological and medical sciences ; Diseases of red blood cells ; Drug Hypersensitivity - diagnosis ; Female ; Ferric Compounds - administration & dosage ; Ferric Compounds - adverse effects ; Glucaric Acid ; Hematologic and hematopoietic diseases ; hemodialysis ; Humans ; iron deficiency ; iron sucrose ; Kidney Failure, Chronic - complications ; Kidney Failure, Chronic - mortality ; Kidney Failure, Chronic - therapy ; Male ; Medical sciences ; Metabolic diseases ; Metals (hemochromatosis...) ; Middle Aged ; Nephrology. Urinary tract diseases ; Other metabolic disorders ; Renal Dialysis ; safety ; Sepsis - mortality</subject><ispartof>Kidney international, 2004-09, Vol.66 (3), p.1193-1198</ispartof><rights>2004 International Society of Nephrology</rights><rights>2004 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Sep 2004</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c477t-7cccde886fc3adc1e69ead259c2d53a6ed4d53cf6f013e24fa0cf392292895013</citedby><cites>FETCH-LOGICAL-c477t-7cccde886fc3adc1e69ead259c2d53a6ed4d53cf6f013e24fa0cf392292895013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16071540$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15327417$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Aronoff, George R.</creatorcontrib><creatorcontrib>Bennett, William M.</creatorcontrib><creatorcontrib>Blumenthal, Samuel</creatorcontrib><creatorcontrib>Charytan, Chaim</creatorcontrib><creatorcontrib>Pennell, J.Phillip</creatorcontrib><creatorcontrib>Reed, John</creatorcontrib><creatorcontrib>Rothstein, Marcos</creatorcontrib><creatorcontrib>Strom, James</creatorcontrib><creatorcontrib>Wolfe, Anthony</creatorcontrib><creatorcontrib>Van Wyck, David</creatorcontrib><creatorcontrib>Yee, Jerry</creatorcontrib><creatorcontrib>For The United States Iron Sucrose (Venofer®) Clinical Trials Group</creatorcontrib><creatorcontrib>United States Iron Sucrose (Venofer) Clinical Trials Group</creatorcontrib><title>Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens</title><title>Kidney international</title><addtitle>Kidney Int</addtitle><description>Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens.
Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>anemia</subject><subject>Anemia - drug therapy</subject><subject>Anemia - etiology</subject><subject>Anemia - mortality</subject><subject>Anemias. Hemoglobinopathies</subject><subject>Biological and medical sciences</subject><subject>Diseases of red blood cells</subject><subject>Drug Hypersensitivity - diagnosis</subject><subject>Female</subject><subject>Ferric Compounds - administration & dosage</subject><subject>Ferric Compounds - adverse effects</subject><subject>Glucaric Acid</subject><subject>Hematologic and hematopoietic diseases</subject><subject>hemodialysis</subject><subject>Humans</subject><subject>iron deficiency</subject><subject>iron sucrose</subject><subject>Kidney Failure, Chronic - complications</subject><subject>Kidney Failure, Chronic - mortality</subject><subject>Kidney Failure, Chronic - therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Metals (hemochromatosis...)</subject><subject>Middle Aged</subject><subject>Nephrology. 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Hemoglobinopathies</topic><topic>Biological and medical sciences</topic><topic>Diseases of red blood cells</topic><topic>Drug Hypersensitivity - diagnosis</topic><topic>Female</topic><topic>Ferric Compounds - administration & dosage</topic><topic>Ferric Compounds - adverse effects</topic><topic>Glucaric Acid</topic><topic>Hematologic and hematopoietic diseases</topic><topic>hemodialysis</topic><topic>Humans</topic><topic>iron deficiency</topic><topic>iron sucrose</topic><topic>Kidney Failure, Chronic - complications</topic><topic>Kidney Failure, Chronic - mortality</topic><topic>Kidney Failure, Chronic - therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic diseases</topic><topic>Metals (hemochromatosis...)</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Other metabolic disorders</topic><topic>Renal Dialysis</topic><topic>safety</topic><topic>Sepsis - mortality</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Aronoff, George R.</creatorcontrib><creatorcontrib>Bennett, William M.</creatorcontrib><creatorcontrib>Blumenthal, Samuel</creatorcontrib><creatorcontrib>Charytan, Chaim</creatorcontrib><creatorcontrib>Pennell, J.Phillip</creatorcontrib><creatorcontrib>Reed, John</creatorcontrib><creatorcontrib>Rothstein, Marcos</creatorcontrib><creatorcontrib>Strom, James</creatorcontrib><creatorcontrib>Wolfe, Anthony</creatorcontrib><creatorcontrib>Van Wyck, David</creatorcontrib><creatorcontrib>Yee, Jerry</creatorcontrib><creatorcontrib>For The United States Iron Sucrose (Venofer®) Clinical Trials Group</creatorcontrib><creatorcontrib>United States Iron Sucrose (Venofer) Clinical Trials Group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Kidney international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Aronoff, George R.</au><au>Bennett, William M.</au><au>Blumenthal, Samuel</au><au>Charytan, Chaim</au><au>Pennell, J.Phillip</au><au>Reed, John</au><au>Rothstein, Marcos</au><au>Strom, James</au><au>Wolfe, Anthony</au><au>Van Wyck, David</au><au>Yee, Jerry</au><aucorp>For The United States Iron Sucrose (Venofer®) Clinical Trials Group</aucorp><aucorp>United States Iron Sucrose (Venofer) Clinical Trials Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens</atitle><jtitle>Kidney international</jtitle><addtitle>Kidney Int</addtitle><date>2004-09-01</date><risdate>2004</risdate><volume>66</volume><issue>3</issue><spage>1193</spage><epage>1198</epage><pages>1193-1198</pages><issn>0085-2538</issn><eissn>1523-1755</eissn><coden>KDYIA5</coden><abstract>Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens.
Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15327417</pmid><doi>10.1111/j.1523-1755.2004.00872.x</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over anemia Anemia - drug therapy Anemia - etiology Anemia - mortality Anemias. Hemoglobinopathies Biological and medical sciences Diseases of red blood cells Drug Hypersensitivity - diagnosis Female Ferric Compounds - administration & dosage Ferric Compounds - adverse effects Glucaric Acid Hematologic and hematopoietic diseases hemodialysis Humans iron deficiency iron sucrose Kidney Failure, Chronic - complications Kidney Failure, Chronic - mortality Kidney Failure, Chronic - therapy Male Medical sciences Metabolic diseases Metals (hemochromatosis...) Middle Aged Nephrology. Urinary tract diseases Other metabolic disorders Renal Dialysis safety Sepsis - mortality |
| title | Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens |
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